ABSTRACT
OBJECTIVE:To establish a method for the determination of the content and molar ratio of Ornithine aspartate for in-jection. METHODS:HPLC was performed on the column of Thermo HYPERSIL Aps-2 amino column with mobile phase of aceto-nitrile-0.05mol/L Potassium dihydrogen phosphate solution,the flow rate was 0.9 ml/min,the column temperature was 30℃,the de-tection wavelength was 200 nm,and the injection volume of 20 μl. The results determined by HPLC and potentiometric titration were compared. RESULTS:The linear range of ornithine aspartate was 0.02-10.01 mg/ml(r=0.999 9);RSDs of precision,stabili-ty and reproducibility tests were lower than 2%;recovery was 99.15%-100.15%(RSD=0.35%,n=9). The content of 3 batches of Ornithine aspartate for injection was 100.04%-100.64% and molar ratio was 0.982-0.989. The content is similar to the results de-termined by potentiometric titration with national standards. CONCLUSIONS:The method is simple,accurate,specific and sensi-tive,and suitable for the determination of the content and molar ratio of Ornithine aspartate for injection.
ABSTRACT
OBJECTIVE:To establish a method for the content determination of carbohydrates in Osseous and cucumis extract injection. METHODS:Ion chromatography was conducted on the column of Dionex CarboPac PA20 with mobile phase of water-1 mol/L Sodium acetate solution-250 mmol/L Sodium hydroxide solution(gradient elution)at flow rate of 0.45 ml/min,column tem-perature was 35 ℃,and injection volume was 10 μl,detector was electrochemical analysis detector. RESULTS:The linear ranges of galactose,glucose,mannose,sucrose and fructose were 0.5-10.0μg/ml(r>0.998 0);RSDs of precision,stability and reproduc-ibility tests were lower than 2%;recovery was 94.8%-99.1%(RSD=0.52%-0.89%,n=9). CONCLUSIONS:The method is sim-ple,fast and accurate,and can be used for the determination of carbohydrates in Osseous and cucumis extract injection.